Sample processing apparatus, method of outputting processing result by sample processing apparatus, and computer program product

ABSTRACT

Disclosed is a sample processing apparatus, comprising: a sample processing unit for processing a sample with an auxiliary item used to process the sample; an output device for outputting a processing result by the sample processing unit; and a controller for determining whether or not the auxiliary item is appropriate for the sample processing by sample processing unit, and controlling, when determining that the auxiliary item is not appropriate for the sample processing by the sample processing unit, the output device so as to output the processing result and reliability information showing that the processing result has a low reliability. Also disclosed is a method for outputting the processing result by the sample processing apparatus and a computer program product.

RELATED APPLICATIONS

This application is a continuation application of U.S. patentapplication Ser. No. 12/321,658, filed Jan. 22, 2009, now U.S. Pat. No.8,180,573 which claims priority under 35 U.S.C. §119 to Japanese PatentApplication No. JP2008-012463 filed Jan. 23, 2008. Each of theabove-referenced applications is incorporated by reference herein in itsentirety.

TECHNICAL FIELD

The present invention relates to a sample processing apparatus such as ahemocytometer or a smear preparing apparatus that uses an auxiliary itemused to process a sample for processing the sample such as blood, aprocessing result output method by the sample processing apparatus, anda computer program product.

BACKGROUND ART

In hospitals and inspection agencies, a sample analyzer has been used tomeasure an item regarding the properties of a sample such as bloodcollected from a living organism (see U.S. Patent Publication No.2006-210438 for example). The sample analyzer as described above hasbeen generally recommended to be used with dedicated reagent (genuineproduct) specified by a supplier (maker). The reason is therefor thatthe dedicated reagent is optimized to provide an accurate analysisresult by the repetition of evaluation experiments while any sampleanalysis using reagents other than the genuine product (not-genuineproduct) may not provide such an accurate analysis result to cause areduced reliability in the analysis result. This reason also applies toa slide glass in a smear preparing apparatus for example. Specifically,the use of a not-genuine slide glass may cause breakage of ato-be-observed component in the sample, which declines the reliabilityto a prepared sample. When not-genuine stain solution is used in thesmear preparing apparatus, blood cells may not be stained in a favorablemanner, causing an adverse impact on the observation result.

However, there may be a case where a user does not know that the use ofa not-genuine product causes a reduced reliability in the analysisresult for example or a user does not know that the product used by theuser is a not-genuine product. When a patient receives a medical carebased on an analysis result having a reduced reliability for example, anadverse impact may be caused on the patient by an inappropriatetreatment or medication.

SUMMARY OF INVENTION

The scope of the present invention is defined solely by the appendedclaims, and is not affected to any degree by the statements within thissummary.

A first aspect of the present invention is a sample processingapparatus, comprising:

a sample processing unit for processing a sample with an auxiliary itemused to process the sample;

an output device for outputting processing result by the sampleprocessing unit; and

a controller for determining whether or not the auxiliary item isappropriate for sample processing by the sample processing unit, andcontrolling, when determining that the auxiliary item is not appropriatefor the sample processing by the sample processing unit, the outputdevice so as to output the processing result and reliability informationshowing that the processing result has a low reliability.

A second aspect of the present invention is a processing result outputmethod by a sample processing apparatus, comprising:

processing a sample with using an auxiliary item;

acquiring a processing result of the sample processed using theauxiliary item;

determining whether or not the auxiliary item is appropriate for sampleprocessing; and

outputting, when the auxiliary item is determined as inappropriate forthe sample processing, the processing result and reliability informationshowing that the processing result has a low reliability.

A third aspect of the present invention is a computer program product,comprising:

a computer readable medium; and

instructions, on the computer readable medium, adapted to enable ageneral purpose computer to perform operations, comprising:

acquiring a result of a processing of a sample processed with anauxiliary item;

determining whether or not the auxiliary item is appropriate for sampleprocessing; and

outputting, when the auxiliary item is determined as inappropriate forthe sample processing, the processing result and reliability informationshowing that the processing result has a low reliability.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a perspective view illustrating a hemocytometer according to afirst embodiment of the present invention;

FIG. 2 is a block diagram illustrating the configuration of ameasurement section in the hemocytometer of FIG. 1;

FIG. 3 is a block diagram illustrating the configuration of a dataprocessing apparatus in the hemocytometer of FIG. 1;

FIG. 4 illustrates the flow of an RBC/PLT measurement in thehemocytometer of FIG. 1;

FIG. 5 illustrates the flow of an HGB measurement in the hemocytometerof FIG. 1;

FIG. 6 illustrates the flow of a WBC/BASO measurement in thehemocytometer of FIG. 1;

FIG. 7 illustrates the flow of a DIFF measurement in the hemocytometerof FIG. 1;

FIG. 8 illustrates the configuration of an optical detector in thehemocytometer of FIG. 1;

FIG. 9 illustrates a reagent exchange screen displayed in the dataprocessing apparatus in the hemocytometer of FIG. 1;

FIG. 10 is a perspective view illustrating a reagent container used inthe hemocytometer of FIG. 1;

FIG. 11 is a flowchart illustrating a control for determining in thehemocytometer of FIG. 1 whether new reagent offered in exchange for theold one is dedicated reagent (genuine product) or not;

FIG. 12 illustrates a Reagent Code warning screen displayed in the dataprocessing apparatus of the hemocytometer of FIG. 1;

FIG. 13 is a flowchart illustrating a control in the hemocytometer ofFIG. 1 for updating information showing whether the reagent is a genuineproduct or not;

FIG. 14 is a flowchart illustrating a control in the hemocytometer ofFIG. 1 for a startup operation;

FIG. 15 illustrates the warning screen displayed in the data processingapparatus of the hemocytometer of FIG. 1;

FIG. 16 is a flowchart illustrating a control in the hemocytometer ofFIG. 1 of measurement and analysis operations;

FIG. 17 is a flowchart illustrating an analysis result display controlin the hemocytometer of FIG. 1;

FIG. 18 is a flowchart illustrating a warning screen display control ofthe hemocytometer of FIG. 1;

FIG. 19 illustrates the contents of a database that is stored in thehemocytometer of FIG. 1 and that shows the relation between ameasurement item and to-be-used genuine reagent;

FIG. 20 is a flowchart illustrating an analysis result print control inthe hemocytometer of FIG. 1;

FIG. 21 illustrates an example of an analysis result display screendisplayed in the data processing apparatus of the hemocytometer of FIG.1 when genuine reagent is used;

FIG. 22 illustrates an example of an analysis result display screendisplayed in the data processing apparatus of the hemocytometer of FIG.1 when not-genuine reagent is used;

FIG. 23 illustrates a modification example of the analysis resultdisplay screen displayed in the data processing apparatus of thehemocytometer of FIG. 1 when not-genuine reagent is used;

FIG. 24 illustrates a modification example of the analysis resultdisplay screen displayed in the data processing apparatus of thehemocytometer of FIG. 1 when not-genuine reagent is used;

FIG. 25 illustrates a modification example of the analysis resultdisplay screen displayed in the data processing apparatus of thehemocytometer of FIG. 1 when not-genuine reagent is used;

FIG. 26 illustrates a reagent information screen displayed in the dataprocessing apparatus of the hemocytometer of FIG. 1;

FIG. 27 illustrates the reagent information screen displayed in the dataprocessing apparatus of the hemocytometer of FIG. 1;

FIG. 28 illustrates the reagent information screen displayed in the dataprocessing apparatus of the hemocytometer of FIG. 1;

FIG. 29 illustrates an example of an analysis result printed by theprinter of the hemocytometer of FIG. 1 when not-genuine reagent is used;

FIG. 30 is a block diagram illustrating the configuration of a smearpreparing apparatus according to a second embodiment of the presentinvention;

FIG. 31 is a perspective view illustrating a slide glass used in thesmear preparing apparatus of FIG. 30; and

FIG. 32 illustrates reliability information printed by the smearpreparing apparatus of FIG. 30.

DESCRIPTION OF EMBODIMENTS

The preferred embodiments of the present invention will be describedhereinafter with reference to the drawings.

First Embodiment

FIG. 1 is a perspective view illustrating a hemocytometer that is asample processing apparatus according to the first embodiment of thepresent invention. A hemocytometer 1 of this embodiment is composed of:a measurement section 2 that measures or counts blood cells; a dataprocessing apparatus 3 that processes a measurement value outputted fromthe measurement section 2 to obtain an analysis result (processingresult); and a printer 4 that prints the analysis result.

[Configuration of Measurement Section 2]

As shown in FIG. 2, the measurement section 2 includes: a sampledistributor 21 that sucks the blood in a blood collection tube todistribute the blood; a sample preparation section 22 that prepares thedistributed sample; a plurality of detectors 23A to 23C that measuresamples; an analog signal processing circuit 24 that subjects the outputfrom the detectors 23A to 23C to an amplification or filter processingfor example; an A/D converter 25 that converts the output from theanalog signal processing circuit 24 to a digital signal; and a digitalsignal processing circuit 26 that subjects the digital signal to apredetermined waveform processing.

The measurement section 2 also includes: a memory 27 connected to thedigital signal processing circuit 26; a CPU 28 connected to the analogsignal processing circuit 24 and the digital signal processing circuit26; and a LAN adapter 29 connected to the CPU 28. The data processingapparatus 3 is connected to the measurement section 2 via the LANadapter 29. The analog signal processing circuit 24, the A/D converter25, the digital signal processing circuit 26, and the memory 27constitute a signal processing circuit 30 to electric signals outputtedfrom the detectors 23A to 23C.

The sample distributor 21 is configured to dispense a predetermineddistribution amount of blood to the sample preparation section 22. Thesample preparation section 22 is also configured to prepare ameasurement sample out of the blood and reagent dispensed from thesample distributor 21 to supply the prepared measurement sample to thedetectors 23A to 23C. The detectors 23A to 23C are composed of: anRBC/PLT detector 23A; an HGB detector 23B; and an optical detector 23C.

(Details of Measurement by RBC/PLT Detector 23A)

The RBC/PLT detector 23A carries out the measurement of the number ofred blood cells (RBC measurement) and the measurement of the number ofplatelets (PLT measurement). FIG. 4 illustrates the flow of themeasurement by the RBC/PLT detector 23A. The blood in a blood collectiontube 51 is sucked through a suction pipette to a sampling valve 52 andis quantitated in a predetermined amount by the sampling valve 52. Thequantitated blood is diluted by the first reagent for the RBC/PLTmeasurement and the resultant diluted sample is sent to an RBC samplechamber 53. Thereafter, the diluted sample and the second reagent aresent to the RBC/PLT detector 23A and RBC and PLT are counted by theRBC/PLT detector 23A based on the sheath flow DC detection method. Atthe same time, an HCT (hematocrit value) is calculated based on thered-blood-cell pulse height detection method.

(Details of Measurement by HGB Detector 23B)

The HGB detector 23B measures a hemoglobin content in blood (HGBmeasurement). FIG. 5 illustrates the flow of the measurement by the HGBdetector 23B. The blood in the blood collection tube 51 is suckedthrough a suction pipette into the sampling valve 52 and is quantitatedto a predetermined amount by the sampling valve 52. The quantitatedblood is diluted by the third reagent for HGB measurement and theresultant diluted sample is sent to a flow cell 54 of the HGB detector23B. At the same time, the fourth reagent for HGB measurement is addedto the sample to further dilute the diluted sample by the fourthreagent. As a result, the red blood cells in this diluted sample arehemolyzed and hemoglobin is inverted to SLS-hemoglobin.

Then, the HGB detector 23B directs the light emitted from alight-emitting diode 55 toward the diluted sample through a lens andmeasures the concentration of the SLS-hemoglobin as an absorbance. Then,the HGB detector 23B compares the absorbance with the absorbance of thediluent measured in advance before the diluent is mixed with the sample,thereby performing the HGB measurement.

The RBC and HCT measured by the RBC/PLT detector 23A and the HGBmeasured by the HGB detector 23B are also used for the calculation of amean corpuscular volume (MCV) and a mean corpuscular hemoglobinconcentration (MCHC).

(Details of Measurement by Optical Detector 23C)

The optical detector 23C carries out the fraction measurement of thenumber of white blood cells (WBC measurement), the fraction measurementof basophil in white blood cells (BASO measurement), and the fractionmeasurement of neutrophil (NEUT), lymph cells (LYMPH), monocytes (MONO),eosinophils (EO), and basophils (BASO) in white blood cells (DIFFmeasurement). FIG. 6 illustrates the flow of the WBC measurement and theBASO measurement by the optical detector 23C. The blood in the bloodcollection tube 51 is sucked via a suction pipette into the samplingvalve 52 and is quantitated in a predetermined amount. The quantitatedblood is diluted by the fifth reagent and the resultant diluted sampleis sent to a reaction chamber 56. Then, the reaction is performed inthis status for ten and several seconds, thereby hemolyzing the redblood cells in the diluted sample.

The optical detector 23C receives the diluted sample and the sixthreagent and subjects the diluted sample and the sixth reagent to the WBCmeasurement and the BASO measurement using semiconductor laser based onthe flow cytometry technique.

FIG. 7 illustrates the flow of the DIFF measurement by the opticaldetector 23C. The blood in the blood collection tube 51 is sucked via asuction pipette into the sampling valve 52 and is quantitated in apredetermined amount. The quantitated blood is diluted by the seventhreagent for the DIFF measurement and the resultant diluted sample issent to the reaction chamber 56 while being simultaneously added withthe eighth reagent for further dilution. Then, the reaction is performedin this status for several dozen seconds to hemolyze the red blood cellsin the diluted sample, thereby staining white blood cell.

The optical detector 23C receives the diluted sample and the ninthreagent and subjects the diluted sample and the ninth reagent to theDIFF measurement using semiconductor laser based on the flow cytometrytechnique.

As shown in FIG. 8, the optical detector 23C includes: a light-emittingsection 23 a that emits laser light; an irradiation lens unit 23 b; asheath flow cell 23 c to which laser light is irradiated; a lightcollection lens 23 d provided on an extended line in a direction alongwhich the laser light emitted from the light-emitting section 23 aproceeds; a pinhole 23 e and a PD (photodiode) 23 f; a light collectionlens 23 g, a dichroic mirror 23 h, an optical filter 23 i, a pinhole 23j and a PD 23 k which are provided in a direction intersecting with thedirection along which the laser light emitted from the light-emittingsection 23 a proceeds; and an APD (avalanche photodiode) 231 provided ata side of the dichroic mirror 23 h.

The light-emitting section 23 a is provided to emit light to a sampleflow including a measurement sample passing through the sheath flow cell23 c. The irradiation lens unit 23 b is provided to convert the lightemitted from the light-emitting section 23 a to parallel light. The PD23 f is provided to receive forward-scattered light emitted from thesheath flow cell 23 c.

The dichroic mirror 23 h is provided to separate the side-scatteredlight and the side fluorescence emitted from the sheath flow cell 23 c.Specifically, the dichroic mirror 23 h is provided to cause theside-scattered light emitted from the sheath flow cell 23 c to enter thePD 23 k and to cause the side fluorescence emitted from the sheath flowcell 23 c to enter the APD 231. The PD 23 k is provided to receive theside-scattered light. The APD 231 is provided to receive the sidefluorescence. The PDs 23 f, 23 k and the APD 231 have a function toconvert a received light signal to an electric signal, respectively.

The analog signal processing circuit 24 includes amplifiers 24 a, 24 b,and 24 c. The amplifiers 24 a, 24 b, and 24 c are provided to subjectelectric signals outputted from the PDs 23 f, 23 k and the APD 231 toamplification and waveform processings, respectively.

(Reagents Used in the Respective Measurements)

The measurements by the respective detectors 23A to 23C use variousreagents such as diluent, sheath liquid, hemolytic agent, or stainsolution (the first to ninth reagents). As these reagents, dedicatedreagents (genuine products) guaranteed by the supplier of thehemocytometer 1 are recommended. The reason is therefor that thededicated reagent is optimized for the hemocytometer 1 to includecomponents for example so that an accurate analysis result can beobtained in the hemocytometer 1. The hemocytometer 1 according to thisembodiment is designed through repeated evaluation experiments so thatan accurate analysis result can be obtained through an analysis usingthe dedicated reagent. Thus, when any reagent (not-genuine product)other than the dedicated reagent for which the performance is guaranteedby the supplier of the hemocytometer 1 according to this embodiment isused to analyze a sample by the hemocytometer 1, an accurate analysisresult is not guaranteed and the analysis result has a reducedreliability. The dedicated reagent may be any reagent guaranteed by thesupplier regardless of whether the reagent can be used in apparatusesmade by other companies.

In the hemocytometer 1 of this embodiment, the first reagent as agenuine product can be “CELLPACK (II)” (made by SYSMEX CORPORATION), thesecond reagent as a genuine product can be “SE sheath (II)” (made bySYSMEX CORPORATION), the third reagent as a genuine product can be“CELLPACK (II)” same as the first reagent, the fourth reagent as agenuine product can be “SULFOLYSER” (made by SYSMEX CORPORATION), thefifth reagent as a genuine product can be “STOMATOLYSER-FB(II)” (made bySYSMEX CORPORATION), the sixth reagent as a genuine product can be“CELLPACK (II)” same as the first and third reagents, the seventhreagent as a genuine product can be “STOMATOLYSER-4DL” (made by SYSMEXCORPORATION), the eighth reagent as a genuine product can be“STOMATOLYSER-4DS” (made by SYSMEX CORPORATION), and the ninth reagentas a genuine product can be “CELLPACK (II)”.

A hard disk 31 d of the data processing apparatus 3 (see FIG. 3) storestherein a database storing the correspondence between measurement itemsperformed by the respective detectors 23A to 23C and the informationregarding dedicated reagents used in the respective measurement items.FIG. 19 shows the relation between the measurement items and reagents inthis database.

The memory 27 of the measurement section 2 (see FIG. 2) is configured tostore information (determination result information) showing whether newreagent exchanged with the old one is dedicated reagent or not.Specifically, the memory 27 is configured to store the determinationresult information showing the determination result by the CPU 31 a ofthe data processing apparatus 3 (which will be described later) withregard to whether new reagent exchanged with the old one is dedicatedreagent or not, the details of which will be described later.

[Configuration of Data Processing Apparatus 3]

As shown in FIG. 1, the data processing apparatus 3 is composed of apersonal computer (PC) or the like. The data processing apparatus 3includes: a controller 31; a display 32; and an input device 33. Thedata processing apparatus 3 has a function to accept an operation by auser to send an operation instruction to the measurement section 2 andreceives measurement data (measurement value) from the measurementsection 2 to process the measurement data to display the analysisresult. As shown in FIG. 3, the controller 31 is composed of: a CPU 31a; a memorization section consisting of a ROM 31 b, a RAM 31 c, and ahard disk 31 d; a reading apparatus 31 e; an input/output interface 31f; an image output interface 31 g; and a communication interface 31 i.The CPU 31 a, the ROM 31 b, the RAM 31 c, the hard disk 31 d, thereading apparatus 31 e, the input/output interface 31 f, the imageoutput interface 31 g, and the communication interface 31 i areconnected by a bus 31 h.

The CPU 31 a is provided to execute a computer program memorized in theROM 31 b and a computer program loaded to the RAM 31 c. The ROM 31 b isconfigured by a mask ROM, PROM, EPROM, EEPROM or the like in which thecomputer program executed by the CPU 31 a and the data used for this orthe like are recorded.

The RAM 31 c is configured by a SRAM or DRAM or the like. The RAM 31 cis used to read a computer program recorded in the ROM 31 b and the harddisk 31 d. The RAM 31 c is also used as an operation region of the CPU31 a when these computer programs are executed.

In the hard disk 31 d, there are installed various computer programs tobe executed by the CPU 31 a and data used to execute the computerprograms, such as an operating system and an application program. Anapplication program 34 a for allowing the data processing apparatus 3 torealize a predetermined function (e.g., a reagent determinationfunction, a screen display function, a print function as will bedescribed later) is also installed in this hard disk 31 d.

The reading apparatus 31 e is configured by a flexible disk drive, aCD-ROM drive, a DVD-ROM drive or the like. The reading apparatus 31 ecan read a computer program or data recorded in a mobile recordingmedium 34. The mobile recording medium 34 stores therein the applicationprogram 34 a. The computer as a data processing apparatus 3 can read theapplication program 34 a from the mobile recording medium 34 to installthe application program 34 a in the hard disk 31 d.

It is noted that the application program 34 a can be provided not onlyfrom the mobile recording medium 34 but also from an external deviceconnected to the computer to have communication therebetween via anelectric communication line (which may be wired or wireless). Forexample, the application program 34 a can be also stored in a hard diskof a server computer on the Internet and the computer may access thisserver computer to download the application program 34 a to install theapplication program 34 a in the hard disk 31 d.

In the hard disk 31 d, an operating system providing a graphical userinterface environment such as Windows manufactured and sold by MicrosoftCorporation is installed for example. The following description willassume that the application program 34 a in this embodiment operates onthe above-mentioned operating system.

The input/output interface 31 f is configured, for example, by a serialinterface such as a USB, IEEE1394 or RS-232C, a parallel interface suchas an SCSI, IDE or IEEE1284, and an analog interface composed of a D/Aconverter, an A/D converter or the like. The input/output interface 31 fis connected to the input device 33 composed of a keyboard and a mouse.A user can use the input device 33 to input data to the data processingapparatus 3.

The communication interface 31 i is an Ethernet interface for example.The data processing apparatus 3 can use the communication interface 31 ito use a predetermined communication protocol (TCP/IP) to send data toand to receive data from the measurement section 2 connected by LANcable. A printer 4 is connected to the data processing apparatus 3 viathe communication interface 31 i.

An image output interface 31 g is connected to the display 32 composedof LCD, CRT or the like. The image output interface 31 g is designed toreceive a video signal from the CPU 31 a to output the video signal tothe display 32. Based on the inputted video signal, the display 32displays an image (screen).

In this embodiment, the CPU 31 a has a function to process themeasurement value measured by the measurement section 2 to obtain ananalysis result to output to the image output interface 31 g a videosignal depending on an analysis result display screen for displaying theanalysis result. FIG. 21 illustrates an example of an analysis resultdisplay screen SC1 displayed in the display 32 of the data processingapparatus 3. The analysis result display screen SC1 includes: a displayregion SC1 a for displaying the numerical data regarding the respectivemeasurement items; and a display region SC1 b for displaying ascattergram or a particle size distribution diagram (hereinafterreferred to as “scattergram or the like”) showing the distribution ofthe number or size of particles in a predetermined item (e.g., WBC, RBC,PLT, DIFF).

In this embodiment, when the reagent used by the user in the measurementsection 2 is exchanged with the new one, the CPU 31 a outputs a videosignal to the image output interface 31 g so that a reagent exchangescreen SC3 shown in FIG. 9 is displayed in the display 32. This reagentexchange screen SC3 is configured to allow the user to input a uniqueReagent Code 60 a consisting of 27 digits provided to a reagentcontainer 60 (see FIG. 10). The hemocytometer 1 is also configured toallow the user to input the Reagent Code 60 a by using a bar codereading apparatus (not shown) to read a bar code 60 b displayed at theupper part of the Reagent Code 60 a. The Reagent Code means informationunique to the dedicated reagent (genuine product) that is appropriatefor the measurement by the measurement section 2 (e.g., an encryptedreagent code of 27 digits storing an expiration date or a lot No. forproviding traceability for example). The Reagent Code 60 a is encryptedby a predetermined function and is configured so that the CPU 31 a candetermine, based on encrypted alphameric characters, whether or not thereagent is a dedicated reagent (genuine product) appropriate for the useby the measurement section 2.

The CPU 31 a is also configured to measure the remaining amount of thereagent being used to store the information for the remaining amount andthe Reagent Code 60 a of the reagent in a storage section such as thehard disk 31 d or a RAM 31 c for example. The storage section can storethe Reagent Codes and the information for remaining amounts of aplurality of reagents used in the past as a reagent exchange hostory.The CPU 31 a is configured to determine, based on both of the ReagentCode 60 a and the information for the remaining amount, whether or notthe new reagent exchanged with the old one is dedicated reagent (genuineproduct).

[Procedure for Determining Dedicated Reagent]

FIG. 11 is a flowchart illustrating the operation for determining in thehemocytometer 1 of this embodiment whether or not the new reagentoffered in exchange for the old one is dedicated reagent (genuineproduct). FIG. 12 illustrates a Reagent Code warning screen in thehemocytometer 1 of this embodiment shown in FIG. 1. Next, with referenceto FIG. 9 to FIG. 12, a genuine product determination operation will bedescribed that determines, in the hemocytometer 1 of this embodiment,whether or not the new reagent offered in exchange for the old one isdedicated reagent (genuine product). The operation described below is anoperation controlled by the CPU 31 a of the data processing apparatus 3.

In Step S1 of FIG. 11, the reagent exchange screen SC3 shown in FIG. 9is displayed to prompt the user to input a Reagent Code. The reagentexchange screen SC3 is displayed on the display 32 when a reagentexchange icon in a menu screen (not shown) is double-clicked by theuser. Step S2 allows the user to input, through the reagent exchangescreen SC3, the Reagent Code 60 a of 27 digits (see FIG. 10) applied tothe reagent to determine whether an “execute” button SC3 a is depressed(selected) or not. When the “execute” button SC3 a is not depressed,then this determination is repeated. When the “execute” button SC3 a isdepressed, Step S3 determines whether the inputted Reagent Code iscorrect or not. Specifically, Step S3 determines whether the inputtedReagent Code is composed of alphameric characters correctly preparedbased on an algorithm used in the encryption. When the inputted ReagentCode is the correct one, then the lot No. and the expiration date storedin the alphameric characters in an encrypted manner are decrypted andare displayed in the respective sections in the reagent exchange screenSC3. When the inputted Reagent Code is the correct one, then theprocessing proceeds to Step S4.

When the Reagent Code is not the correct one, then Step S7 displays aReagent Code warning screen SC4 as shown in FIG. 12. The Reagent Codewarning screen SC4 displays a warning message that the Reagent Code isnot correctly inputted and the analysis result cannot be guaranteed andthe user is asked to determine whether the reagent exchange is performedor not.

Step S8 of FIG. 11 determines whether an OK button SC4 a or a cancelbutton SC4 b in the Reagent Code warning screen SC4 is depressed. Whenthe cancel button SC4 b is depressed, then the processing returns toStep S1. When the OK button SC4 a is depressed, Step S9 stores, in astorage section such as the RAM 31 c, the determination resultinformation showing that the reagent is nondedicated reagent(not-genuine product), thereby completing the operation.

When the Reagent Code is the correct one, Step S4 determines whether ornot the inputted Reagent Code is identical with the one of Reagent Codesof a plurality of reagents used in the past stored in the storagesection as a part of a reagent exchange history. When the identical oneis not found, then the processing goes to Step S5 to store, in thestorage section, the determination result information showing that thereagent is dedicated reagent (genuine product), thereby completing theoperation.

When the inputted Reagent Code is identical with any one of a pluralityof reagents stored in the storage section, Step S6 checks theinformation regarding the remaining amount of the reagent that is storedin the storage section together with the Reagent Code. When the storagesection stores no reagent remaining amount corresponding to the inputtedReagent Code, this means that all reagents are already used and areexchanged with the new ones. Thus, it can be determined that anondedicated reagent is falsely used as a dedicated reagent (e.g.,another reagent (not-genuine product) may be refilled in a container ofthe reagent to be exchanged, or a Reagent Code applied to dedicatedreagent (genuine product) used in the past may be inputted and thereagent exchanged as the new one may be a not-genuine product). Thus,when there is no reagent remaining amount stored in the storage sectionin Step S6, then the processing proceeds to Step S7 to display theReagent Code warning screen SC4. When there is a reagent remainingamount, the reagent is determined as dedicated reagent (genuine product)and the processing proceeds to Step S5. By carrying out the genuineproduct determination operation when the reagent is exchanged with thenew one as described above, there can be supressed where any reagentunchecked with regard to whether the new reagent is a dedicated reagent(genuine product) or not is newly set as a substitute for the old oneand is used for measurement and analysis.

[Procedure for Updating Reagent Information]

FIG. 13 is a flowchart illustrating the operation for updating theinformation showing whether the reagent is a genuine product or not inthe hemocytometer 1 according to this embodiment. Next, with referenceto FIG. 11 and FIG. 13, an operation for updating a genuine product flagin the hemocytometer 1 according to this embodiment will be described.This operation for updating a genuine product flag updates theinformation showing whether the reagent is a genuine product or not. Theoperation described below is an operation controlled by the CPU 31 a ofthe controller 31 of the data processing apparatus 3 and the CPU 28 ofthe measurement section 2.

First, the data processing apparatus 3 in Step S101 of FIG. 13determines whether the reagent exchange is performed or not. When thereagent exchange is not performed, then this determination is repeated.Specifically, whether the reagent exchange is performed or not isdetermined based on whether the genuine product determination operationin the flow shown in FIG. 11 is completed or not. When the genuineproduct determination operation in the flow shown in FIG. 11 iscompleted, this means that the reagent exchange is performed. Thus, StepS102 transmits a signal showing the determination result information tothe measurement section 2, thereby completing the operation.

In Step S201, the measurement section 2 receives the signal showing thedetermination result information that is transmitted from the dataprocessing apparatus 3. In Step S202, a sequence control in the reagentexchange is performed. This sequence control in the reagent exchange isa preparative operation for performing the next measurement. Thissequence control will be described specifically. After the reagentexchange, air may exist in a tube through which the reagent flows or noreagent may exist in a space in a tube that should accommodate thereagent. To solve this, the sequence control in the reagent exchangesucks reagent from a newly-set reagent container and fills reagent inthe tube.

Next, based on the received signal showing the determination resultinformation, Step S203 stores, in the memory 27 (see FIG. 2), theinformation showing whether the reagent is dedicated reagent (genuineproduct) or not. Specifically, when the reagent is dedicated reagent(genuine product), then the information showing whether the reagent isdedicated reagent (genuine product) or not is updated so that a genuineproduct flag stored in the memory 27 is in an ON status. When thereagent is nondedicated reagent (not-genuine product), then theinformation showing whether the reagent is dedicated reagent (genuineproduct) or not is updated so that a genuine product flag stored in thememory 27 is in an OFF status. Thereafter, the operation of themeasurement section 2 is completed.

[Operation Procedure for Starting Hemocytometer Up]

FIG. 14 is a flowchart illustrating the operation at the startup of thehemocytometer 1 in this embodiment. FIG. 15 illustrates a warning screenof the hemocytometer 1 shown in FIG. 1. Next, with reference to FIG. 14and FIG. 15, the operation at the startup of the hemocytometer 1 in thisembodiment will be described. The operation described below is anoperation controlled by the CPU 31 a of the controller 31 of the dataprocessing apparatus 3 and the CPU 28 of the measurement section 2.

First, Step S211 of FIG. 14 sends a reagent information signal to thedata processing apparatus 3 based on the status of the genuine productflag stored in the memory 27 of the measurement section 2. Specifically,when the genuine product flag is in the ON status, a signal showing thatthe to-be-used reagent is dedicated reagent (genuine product) is sent tothe data processing apparatus 3. When the genuine product flag is in theOFF status, a signal showing that the to-be-used reagent is nondedicatedreagent (not-genuine product) is sent, thereby completing the operation.

In Step S111, the data processing apparatus 3 receives the reagentinformation signal sent from the measurement section 2. In Step S112,whether the reagent is dedicated reagent (genuine product) or not ischecked based on the received reagent information signal. When thereagent is dedicated reagent (genuine product), then the operation iscompleted. When the reagent is nondedicated reagent (not-genuineproduct) on the other hand, Step S113 displays a warning screen SC5 asshown in FIG. 15. The warning screen SC5 displays a warning message thata Reagent Code is not correctly inputted during the reagent exchange andthe analysis result cannot be guaranteed. By displaying the warningscreen SC5 at the startup as described above, the user can recognize,prior to the start of measurement and analysis, that the to-be-obtainedanalysis result has a low reliability. Thereafter, the operation of thedata processing apparatus 3 is completed.

[Procedure for Measurement and Analysis Operations of Hemocytometer]

FIG. 16 is a flowchart illustrating the measurement and analysisoperations in the hemocytometer 1 according to this embodiment. Next,the following section will describe the measurement and analysisoperations by the hemocytometer 1 of this embodiment including thedisplay of an analysis result by the display 32 and an operation by theprinter 4 to print the analysis result.

First, when the start of a measurement operation is instructed, then thedata processing apparatus 3 in Step S120 determines whether the reagentto be used in the analysis is a genuine product or not. When the reagentis a genuine product, then the processing proceeds to Step S121. Whenthe reagent is not a genuine product, then Step S129 shows that thereagent is not a genuine product and displays a warning screen in thedisplay 32 through which the user is allowed to select the start of ameasurement or the cancel of a measurement. Then, the processingproceeds to Step S130. When the start of a measurement is selectedthrough the warning screen in Step S130, then the processing proceeds toStep S121. When the cancel of a measurement is selected, then themeasurement is cancelled, thereby completing the processing (Step S130).By doing this, a situation can be prevented where the user mistakenlyuses a not-genuine reagent for measurement while not knowing that thereagent is not a genuine product and not wanting to perform themeasurement by the not-genuine product.

On the other hand, the measurement section 2 in Step S221 starts a bloodmeasurement by the measurement section 2. Step S222 determines whetherthe measurement is completed or not. When the measurement is notcompleted, this determination is repeated while continuing themeasurement. When the measurement is completed, then Step S223 sends themeasurement value data via the LAN adapter 29 (see FIG. 2) to the dataprocessing apparatus 3, thereby completing the operation of themeasurement section 2.

In Step S121, the data processing apparatus 3 determines whether themeasurement value data sent from the measurement section 2 is receivedor not. When the measurement value data is received, the measurementvalue is subjected to a processing (analysis processing) in Step S122based on the received measurement value data. Then, Step S123 performsan operation to display the analysis result in the display section 32.

(Processing Procedure for Displaying Analysis Result)

FIG. 17 is a flowchart illustrating an analysis result display controlof the hemocytometer 1 according to this embodiment. In Step S131, thedata processing apparatus 3 determines whether the reagent used in theanalysis is a genuine product or not. This determination is performedbased on the check result checked in the operation at the startup inStep S112 shown in FIG. 14.

When the reagent used in the analysis is a genuine product, then theprocessing proceeds to Step S132 to display the normal analysis resultdisplay screen SC1 shown in FIG. 21 in the display 32. The analysisresult display screen SC1 is a display in which a main tab SC1 d isselected. The display region SC1 a displays numerical data and thedisplay region SC1 b displays a scattergram or the like.

When the reagent used in the analysis is a not-genuine product, then theprocessing proceeds to Step S133 to display, in the display 32, ananalysis result display screen SC2 including a warning message as shownin FIG. 22. This analysis result display screen SC2 is obtained byadding a note SC2 c to the normal analysis result display screen SC1 ofFIG. 21. This note SC2 c shows a text display of information(reliability information) that the reagent used in the analysis is anot-genuine product and the supplier of the hemocytometer 1 cannotguarantee the analysis result. Thus, the user can securely recognize,upon seeing the reliability information of this note SC2 c together withthe analysis result, that the analysis result has a low reliability.

The analysis result display screen SC2 in FIG. 22 on the other handcannot allow the user to identify which measurement item leads to ananalysis result having a low reliability. To solve this, the reliabilityinformation as shown in FIG. 23 to FIG. 25 can be also displayed as amodification example.

FIG. 23 shows an example in which reliability information is added tothe respective measurement items in a numerical data display region SC2a. Specifically, warning marks (icons) IC1 a to IC1 f as a reminderregarding reliability information are added so as to correspond to themeasurement item names and numerical data. The warning marks IC1 a toIC1 f can be added to be followed by the text showing the measurementitem names and numerical data (IC1 a, IC1 d) or to follow such text (IC1b, IC1 e) or also can be added to the background (IC1 c, IC1 f). Throughany of these patterns, the user can accurately recognize, upon seeingthe numerical data display region SC2 a, which measurement item leads toan analysis result having a low reliability.

FIG. 24 shows an example in which reliability information is added to adisplay region SC2 b for displaying a scattergram for example. Thisexample also uses warning marks IC2 a to IC2 d as a reminder regardingthe reliability information. A warning mark can be added to be followedby text showing a item name of a scattergram for example (IC2 b) or tofollow such a text (IC2 a) or can be also added to the background.Alternatively, a warning mark can be also added to the background of ascattergram for example (IC2 c, IC2 d).

FIG. 25 shows an example in which reliability information is added tothe numerical data display region SC2 a as in the example shown in FIG.23. FIG. 25 is different from FIG. 23 in that the reliabilityinformation includes reagent information. Specifically, icons IC3 a toIC3 c obtained by putting “x” marks on different reagent container marksfor the respective reagents are used as warning marks showingreliability information. The warning marks correspond to the textshowing measurement item names. In the example of FIG. 25, the user canrecognize not only which measurement item leads to an analysis resulthaving a low reliability but also which reagent among a plurality ofreagents used for the measurement having a low reliability is anot-genuine product. The icons IC3 a to IC3 c may be also put on textshowing numerical data.

When the reliability information is put on the numerical data orscattergram for example of the respective measurement items as describedabove, Step S133 in FIG. 17 performs a control as described below. FIG.18 is a flowchart illustrating the control of a screen display includinga warning message. The data processing apparatus 3 in Step S141determines whether the reagent used in the respective measurement itemsand scattergram for example is a genuine product or not. When thereagent used in the respective measurement items and scattergram forexample is a genuine product, Step S143 determines whether thedetermination is completed with regard to all measurement items andscattergram for example. When the determination is not yet completed,then the processing returns to Step S141. When the reagent used in thepredetermined measurement items and scattergram for example is not agenuine product, Step S142 determines that warning marks (reliabilityinformation) are added to the measurement items and scattergram forexample and the processing proceeds to Step S143.

When Step S143 determines that the determination for all measurementitems and scattergram for example is completed, then Step S144 allowsthe display 32 to display the analysis result display screen SC2 (SC2 aand SC2 b of FIG. 23 to FIG. 25) in which warning marks are put on themeasurement items and scattergram for example determined to have thereonwarning marks. Thereafter, the processing proceeds to Step S124 of FIG.16.

In FIG. 16, Step S124 determines whether the display of the reagentinformation screen is instructed or not. When the display of the reagentinformation screen is instructed, Step S125 allows the reagentinformation screen to be displayed in the display 32. Specifically, whenthe user clicks the note SC2 c as reliability information shown in FIG.22 or the warning marks IC1 a to IC3 c shown in FIG. 23 to FIG. 25, thena reagent information screen SC6 as shown in FIG. 26 is displayed. Thisreagent information screen SC6 displays a genuine product name, the lotNo., and the expiration date of a to-be-used reagent used in apredetermined measurement item (WBC in this case) as well as a graphicshowing a portion to which the reagent is supplied (reaction chamber ordetector). With regard to a reagent not using a genuine product, thewarning mark IC4 showing reliability information is put and “unknown” ora blank space is displayed in display columns for displaying the lot No.and expiration date. Thus, the user can instantly recognize, upon seeingthe reagent information screen SC6, reagent supplied to which portion isa not-genuine product.

Another example of the reagent information screen is shown in FIG. 27 inwhich the analysis result display screen SC2 includes a reagentinformation tab SC2 d. The user can select this tab SC2 d to display areagent information screen SC2 e. This reagent information screen SC2 edisplays the name, the lot No. and expiration date of a reagent that isa genuine product. With regards to a reagent not using a genuineproduct, “unknown” or a blank space is displayed in display columns fordisplaying the lot No. and expiration date and a text display isdisplayed to show the information showing that the analysis resultcannot be guaranteed for any measurement item using the reagent togetherwith a warning mark IC5 as reliability information. Thus, the user canrecognize, upon seeing this reagent information screen SC2 e, whichreagent is a not-genuine product and a measurement item that leads to ananalysis result having a low reliability.

As another example of reagent information screen, the note SC2 c asreliability information shown in FIG. 22 and the warning marks IC1 a toIC3 c of FIG. 23 to FIG. 25 can be also clicked by the user to display areagent information screen SC7 as shown in FIG. 28. This reagentinformation screen SC7 displays a text display of the informationregarding a reagent of a genuine product (e.g., performance andadvantage of the genuine product and how to obtain the product). Byseeing the display of such information, the user can recognize thepriority and significance of the use of a genuine product and cansmoothly obtain the genuine product.

Step S126 of FIG. 16 determines whether a printing operation of theanalysis result is instructed or not. A print instruction is issued whenthe user clicks print button (print icon) IC6 provided in tool bars inthe analysis result display screens SC1 and SC2 as shown in FIG. 21 andFIG. 22. When a print instruction is issued, then the processingproceeds to Step S127 to allow the printer 4 to print the analysisresult on a paper.

FIG. 20 is a flowchart illustrating the control of the printing of theanalysis result. Step S151 determines whether the reagent being used isa genuine product or not. This determination is performed based on thecheck result checked in Step S112 in the operation at the startup shownin FIG. 14. When the reagent is a genuine product, then Step S152 allowsthe analysis result to be printed with a normal format. Thereafter, theprocessing proceeds to Step S128 of FIG. 16. When the reagent is anot-genuine product, Step S153 allows the analysis result to be printedwith a format including a warning message.

FIG. 29 illustrates an analysis result printed with a format including awarning message. In FIG. 29, various information regarding anexamination (e.g., a measurement item name, numerical data, ascattergram) is printed on a paper S. This information is printed sothat the reliability information Sa is superposed on the information andthe reliability information Sa is printed as a background print. Thereliability information Sa shows that reagent is a not-genuine productand the supplier of the hemocytometer 1 cannot guarantee the analysisresult. Thus, the user can securely recognize the analysis result andthe reliability information without missing the information.Furthermore, a situation can be also prevented where reliabilityinformation Sa is cut off when the printed analysis result including thereliability information Sa is presented to a patient or the outside forexample.

An analysis result can be also printed so as to include the reliabilityinformation shown in FIG. 23 to FIG. 25 (warning marks IC1 a to IC3 c)that corresponds to the display of a measurement item name, numericaldata, or a scattergram for example. Alternatively, instead of displayingboth of the analysis result and the warning on one sheet as shown inFIG. 29, the analysis result and the warning may be also printed ondifferent papers.

Step S128 of FIG. 16 determines whether the instruction to complete thescreen display is issued or not. When the instruction is issued, thenthe operation is completed. When the instruction is not issued, theprocessing returns to Step S124.

As described above, the hemocytometer 1 according to this embodimentdetermines whether the reagent is appropriate for the measurement of asample by the measurement section 2 or not based on the Reagent Code 60a received by the reagent exchange screen SC3. Based on thedetermination result, the analysis result and the reliabilityinformation showing that the analysis result has a low reliability areoutputted together. Thus, the user can recognize not only the analysisresult but also the reliability of the analysis result. This can avoid asituation where a patient is subjected to an inappropriate treatment ormedication based on the analysis result having a low reliability.

Also according to this embodiment, when the reagent is determined to bea nondedicated reagent (not-genuine product) that is not appropriate forthe analysis, the display 32 displays the warning screen SC5 at thestartup of the hemocytometer 1. This allows the user to recognize, priorto carrying out the analysis, that the analysis result has a lowreliability.

Also according to this embodiment, whether the reagent is a dedicatedreagent (genuine product) appropriate for the sample analysis by themeasurement section 2 or not is determined based on both of theinformation for the Reagent Code 60 a and the information for thereagent remaining amount received by the reagent exchange screen SC3.Thus, the determination regarding whether the reagent is a dedicatedreagent (genuine product) or not can be performed accurately.

Second Embodiment

FIG. 30 is a block diagram illustrating the configuration of a smearpreparing apparatus 100 that is a sample processing apparatus accordingto the second embodiment of the present invention. The smear preparingapparatus 100 is provided adjacent to the above-described hemocytometer1 for example. The smear preparing apparatus 100 prepares, based on theanalysis result by the hemocytometer 1, a smear to a sample requiring areexamination using a smear. The smear is also prepared by reagent suchas stain solution, diluent or the like.

The smear preparing apparatus 100 includes: a controller 101, a displayoperating section 102, a cassette container 103, a cassette carrier 104,a sample preparing section 105, a staining section 106, and a storagesection 107. The controller 101 is composed of a CPU 101 a and a memory101 b such as ROM or RAM for example. The controller 101 has a functionto control the operation of the smear preparing apparatus 100. Thedisplay operating section 102 is composed of a touch panel through whichvarious settings for the smear preparing apparatus 100 can be inputtedand the status can be displayed for example.

The cassette container 103 stores therein a cassette (not shown) thatcan accommodate a slide glass 110 (see FIG. 31) and stain solution for astaining process. The cassette container 103 has a function to send thecassette to the cassette carrier 104. The cassette carrier 104 has afunction to carry the cassette received from the cassette container 103to the sample preparing section 105 and the staining section 106.

The sample preparing section 105 includes: a suction dispensingmechanism 105 a; a smear section 105 b; and a slide glass insertionsection 105 c. The suction dispensing mechanism 105 a has a function tosuck the blood in a blood collection tube automatically supplied from acarrying apparatus (not shown) or a manually supplied blood collectiontube to drip the blood onto the slide glass 110. The smear section 105 bhas a function to smear the blood dripped on the slide glass 110 to drythe blood to allow a printer 105 b 1 to print smear-related information.The slide glass 110 includes, as shown in FIG. 31, a sample preparingregion 110 b and a frost section (information display region) 110 aprovided at one side of the sample preparing region 110 b. The printer105 b 1 prints the smear-related information to this frost section 110a.

As shown in FIG. 30, the slide glass insertion section 105 c has afunction to insert the slide glass 110 smeared with the sample to thecassette sent from the cassette carrier 104. The slide glass 110inserted into the cassette is carried by the cassette carrier 104 to thestaining section 106.

The staining section 106 supplies stain solution (reagent) to thecassette sent from the cassette carrier 104 to stain the slide glass 110smeared with the sample. The storage section 107 has a function to storea cassette accommodating the slide glass 110 stained by the stainingsection 106. The stained slide glass 110 stored in this storage section107 is subjected to an analysis by a visual inspection for example. Inthis manner, the smear preparing apparatus 100 prepares a smear as aprocessing result by processing the blood by the reagent as describedabove. The prepared smear is taken out by the user of the smearpreparing apparatus 100 or a carrying mechanism (not shown) to theoutside of the apparatus.

As shown in FIG. 31, the smear-related information such as a date, apatient name, or a sample No. can be printed on the frost section 110 aof the slide glass 110. The printer 105 b 1 is configured to print thereliability information on the frost section 110 a with regard to asmear prepared using a reagent of a not-genuine product. Thedetermination regarding whether the reagent is a genuine product or notand the control for printing the reliability information are performedby the CPU 101 a of the controller 101 in the same manner as in thefirst embodiment.

FIGS. 32( a) to 32(c) illustrate an example of a print of thereliability information. In FIG. 32( a), texts can be printed in threelines in the frost section 110 a so that the first line includes a date,the second line includes a sample No. or the like, and the third lineincludes reliability information 120 showing that “a not-genuine reagentis used” for example.

In FIG. 32( b), texts can be printed on the uppermost part and thelowermost part of the frost section 110 a and a one-dimensional bar codecan be printed on the center. The reliability information 120 showingthat “a not-genuine reagent is used” is printed in the upper or lowerline of the bar code. The bar code may be also a two-dimensional barcode.

In FIG. 32( c), three lines are printable in the frost section 110 a asin those shown in FIG. 32( a). However, an image of “x” mark is printedover a reagent container graphic that is different depending on the typeof the reagent as the reliability information 120. Through this image,the user can recognize that the reagent is not a genuine product andwhich reagent is a not-genuine product. In the examples shown in FIGS.32( a) and 32(b), the type of the reagent using a not-genuine productcan be also printed by a text or a graphic.

The respective embodiments disclosed herein are the illustrative ones inall respects and should be interpreted as the not limitative ones. Thescope of the present invention is not defined by the above-describeddescription of the embodiments but is defined by the claims and includesall modifications within the intention and scope equivalent to theclaims.

For example, although the above-described embodiments have described anexample in which the present invention is applied to the hemocytometer 1and the smear preparing apparatus 100 as the sample processingapparatus, the invention is not limited to this. The invention can bealso used to other medical sample processing apparatuses such as a bloodcoagulation analyzer, an immunity analyzer, a urine visible componentanalyzer so long as the sample processing apparatus uses dedicatedreagent to process a sample.

In the first embodiment, an example of the configuration has been shownin which the warning screen is displayed at the startup. However, thepresent invention is not limited to this. A warning screen may be alsodisplayed whenever the analysis result display screen is displayed.

In the above embodiment, a configuration has been shown to determinewhether the reagent is a dedicated reagent (genuine product) or anondedicated reagent (not-genuine product). However, the presentinvention is not limited to this. Another configuration may be also usedthat includes not only the determination regarding whether the reagentis a dedicated reagent or not but also a determination to determinewhether the reagent has an expired expiration date or not by comparingthe expiration date of the reagent with a measurement date. When thereagent does not have an expired expiration date, a normal screendisplay or a normal print is performed. When the reagent has an expiredexpiration date, reliability information showing that the reagent has anexpired expiration date can be displayed or printed.

In the above embodiment, a configuration has been shown to determinewhether the reagent is a dedicated reagent (genuine product) or anondedicated reagent (not-genuine product). However, the presentinvention is not limited to this. Another configuration may be also usedin which another auxiliary item used to process a sample can bedetermined with regard to whether the auxiliary item is a genuineproduct or a not-genuine product. When the substance is a not-genuineproduct, the reliability information is outputted. For example, theslide glass 110 used in the second embodiment can be determined withregard to whether the slide glass 110 is a genuine product or anot-genuine product. When the slide glass 110 is a not-genuine product,the reliability information is outputted. Still another configurationcan be also used in which a disposable cuvette for storing a sample thatis used for an optical measurement by a blood coagulation analyzer, animmune measurement apparatus, or a biochemical measurement apparatus forexample is determined with regard to whether the cuvette is a genuineproduct or a not-genuine product. When the cuvette is a not-genuineproduct, the reliability information is outputted. Still anotherconfiguration can be also used in which a disposable dispensing pippetfor sucking a sample or a reagent that is used in a blood coagulationanalyzer, an immune measurement apparatus, or a biochemical measurementapparatus for example is determined with regard to whether thedispensing pipette is a genuine product or a not-genuine product. Whenthe dispensing pipette is a not-genuine product, the reliabilityinformation is outputted.

The invention claimed is:
 1. A sample analysis apparatus, comprising: asample analyzing unit configured to analyze a biological or chemicalsample by using an auxiliary item; an input device configured to inputan identifying information associated with the auxiliary item; an outputdevice configured to output an analysis result by the sample analyzingunit, the output device comprising a printer; and a controllerconfigured to receive an input of the identifying information from theinput device, determine whether the received identifying information isthat of genuine product, control, in response to determining that thereceived identifying information is not that of a genuine product, theprinter so as to printout, the analysis result and an information thatthe analysis result is not guaranteed, in a manner such that theinformation is superposed on the analysis result.
 2. The sample analysisapparatus according to claim 1, wherein the auxiliary item is a reagentto be used on the sample analyzing unit.
 3. The sample analysisapparatus according to claim 2, wherein the output device furthercomprises a display, and the controller controls the display to output ascreen which allows a user to input the identifying information assignedto a reagent to be used on the analyzing unit.
 4. The sample analysisapparatus according to claim 1, wherein the identifying informationcomprises alphameric characters, and the controller receives the inputof the identifying information from the input device.
 5. The sampleanalysis apparatus according to claim 4, wherein the identifyinginformation is indicated in a form of barcode on the reagent, the inputdevice comprises a barcode reader, and the controller receives the inputof the identifying information from the barcode reader.
 6. The sampleanalysis apparatus according to claim 4, wherein the identifyinginformation is encrypted by a predetermined algorithm, and thepredetermined condition is that the received identifying information isalphameric characters which is in conformity with characters generatedbased on a predetermined algorithm.
 7. The sample analysis apparatusaccording to claim 1, wherein the output device further comprises adisplay, and wherein in response to determining that the receivedidentifying information is not that of a genuine product, the controllercontrols the display to output a warning screen that the identifyinginformation is not input correctly.
 8. The sample analysis apparatusaccording to claim 1, wherein the output device further comprises adisplay, and wherein in response to determining that the receivedidentifying information is not that of a genuine product, the controllercontrols the display to output a warning screen that the analysis resultcannot be guaranteed.
 9. The sample analysis apparatus according toclaim 2, wherein the output device further comprises a display, andwherein in response to determining that the received identifyinginformation is not that of a genuine product, the controller controlsthe display to output a warning screen that shows a user options whetherhe/she executes reagent exchange while showing an information that ananalysis result to be obtained is not guaranteed.
 10. The sampleanalysis apparatus according to claim 2, wherein the sample analyzingunit is configured to analyze the sample with regard to a plurality ofanalysis items, the controller the controls, in response to determiningthat the received identifying information is not that of a genuineproduct, the output device so as to output the analysis result for theplurality of the analysis items and warning being for at least one ofthe analysis item.
 11. The sample analysis apparatus according to claim1, wherein the analysis result comprises a distribution chart.
 12. Thesample analysis apparatus according to claim 11, wherein thedistribution chart is a histogram.
 13. The sample analysis apparatusaccording to claim 11, wherein the distribution chart is a scattergram.14. The sample analysis apparatus according to claim 10, wherein thewarning is output in form of a mark that alters an appearance of areagent container.
 15. The sample analysis apparatus according to claim2, wherein the output device further comprises a display, the sampleanalyzing unit is configured to analyze the sample by using plural kindsof reagents, the controller is configured to receive the input of theidentifying information with regard to each of the plural kinds of thereagents from the input device, the controller is configured to controlthe display to output a reagent information screen which shows a list ofreagents used on the sample analyzing unit, and the controller controls,in response to determining that the received identifying information isnot that of a genuine product, the display so as to output warning onthe reagent information screen corresponding to the reagent which is nota genuine product.
 16. The sample analysis apparatus according to claim2, wherein the output device further comprises a display, and thecontroller is configured to control the display to output a screenshowing how to obtain genuine product.
 17. A sample analyzing methodconducted on a sample analyzer, comprising steps of: receiving an inputof the identifying information of a reagent used on the sample analyzer;determine whether the received identifying information is that of agenuine product, analyzing a biological or chemical sample by using thereagent; and outputting an analysis result of the sample, wherein in thestep of outputting, in response to determining that the receivedidentifying information is not that of a genuine product, the analysisresult and an information that the analysis result is not guaranteed areprinted out in a manner such that the information is superposed on theanalysis result.
 18. The sample analysis apparatus according to claim 1,wherein the analyzing unit is configured to count blood cells.
 19. Thesample analysis apparatus according to claim 18, wherein the auxiliaryitem is one of diluent, sheath liquid, hemolytic agent, and stainsolution.
 20. The sample analysis apparatus according to claim 1,wherein the auxiliary item is a cuvette.